COVID-19 Update

What’s Next for COVID-19 Vaccines and Variants?

More technologies and treatments are emerging for COVID-19—along with new variants.

Key Elements for Assay Transfer Success

Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers.

GMP/GDP Inspection Challenges and Opportunities

An annual survey on inspections and audits has revealed opportunities to use more flexible approaches to optimize processes.

FDA Seeks to Simplify COVID-19 Vaccination Program

January 30, 2023

FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.

Providing a Snapshot of the Industry

January 20, 2023

CRB’s latest industry report includes an expanded audience to include many European countries, which has provided some interesting insights.

Opening Up Opportunities in 2023

January 03, 2023

Bio/pharma has evolved and adapted to a variety of challenges in 2022, but what might be on the cards for the industry in 2023?

Crossing the Same River Multiple Times

January 03, 2023

Cautiously setting aside pandemic practices, pharma workers appear ready for flux, change, evolution, and expanding molecular diversity.

FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region

December 20, 2022

FDA has announced that bebtelovimab is not currently authorized for emergency use in any region of the US.

Trial Decline

November 02, 2022

Industry and the government must work closely to ensure the UK remains a competitor in the clinical research field.

EMA Extends Use of COVID-19 Vaccines to Children

October 21, 2022

The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.

EMA Recommends Adapted Spikevax Vaccine

October 21, 2022

The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.

FDA Authorizes Bivalent COVID-19 Boosters for Children Ages Five and Older

October 13, 2022

FDA amended its authorization for the Moderna and Pfizer-BioNTech bivalent booster vaccines to permit their use in children as young as five years old.

Pfizer to Supply up to 6 Million PAXLOVID Treatment Courses for Low-and-Middle-Income Countries

September 27, 2022

Pfizer is set to supply global fund up to 6 million treatment courses of its COVID-19 oral treatment, PAXLOVID, for low-and-middle-income countries.